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Completed

NCT Number: NCT06259708

Using Low Intensity Focused Ultrasound to Modulate Deep Brain Areas for Tremor Control in Parkinson's Disease Patients.

Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). They noticed that ET patients initially responded better to the treatment than PD patients, but by the end of the treatment, both groups showed similar improvement. The study also suggested that targeting a specific area of the brain called the Zona Incerta (ZI) may be more beneficial for PD patients. Based on these findings, the investigators plan to use low-intensity focused ultrasound to directly modulate the ZI area and investigate the mechanisms of reduced tremors in PD patients. The investigators will also compare the effectiveness of this approach with the current target, the ventral intermediate nucleus (Vim) of the thalamus. The investigators will use a simulation model to determine the best ultrasound parameters for this new approach and will also examine the impact of the treatment on the brain's network activity using functional Magnetic Resonance Imaging. Success of this project may lay the foundation for finding a more effective target for MRgFUS treatment of PD tremor.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, DMCBH

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of Parkinson's disease
  • Resting tremor score (MDS-UPDRS III 3.17 Rest Tremore Amplitude (RUE or LUE)) ≥ 2
  • Between the ages of 40-80 years
  • Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
  • Patients who are willing to have a partial (~8 cm diameter circular area above the ear) hair shaving.

Exclusion criteria

  • Atypical Parkinsonism
  • History of essential tremor
  • Dementia preventing informed consent
  • Change in Parkinson's medication with the last 2 weeks
  • Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
  • Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
  • Concurrent treatment for PD with Duodopa
  • Concurrent treatment for PD with deep brain stimulation (DBS)
  • Thickness of the temporal bone < 7 mm
  • Individuals should also not participate if they have any of the following contraindications for undergoing fMRI scanning:
  • Cardiac pacemaker, wires, or defibrillator
  • Metal in eye or orbit, including the history of any eye injury involving metal fragments and increased risk due to (history of) working as a metal worker (grinding, machining, or welding)
  • Ferromagnetic aneurysm clip
  • Possibility of pregnancy
  • Artificial heart valve
  • Ear or eye implant, including cochlear implant
  • Brain aneurysm clip
  • Implanted drug infusion pump
  • Electrical stimulator to nerves or bones
  • Coil, catheter, or filter in any blood vessel
  • Orthopedic hardware (artificial joint, plate, screw, rod)
  • Other metallic prostheses
  • Shrapnel, bullets, or other metal fragments
  • Surgery, piercings or tattoos (including tattooed eyeliner) in the last six weeks
  • Medication releasing skin patches (i.e. nicotine, birth control, nitroglycerine)
  • History of claustrophobia

Treatment and study plan

Low Intensity Focused Ultrasound

Device

Sonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim).

Primary outcomes

  1. Tremor

    Time frame: At 50Hz for 40 minutes 30 minutes after intervention

    Finger displacement (angle [deg]).

  2. Tremor

    Time frame: At 50Hz for 40 minutes 30 minutes after intervention

    Finger acceleration (mm/s^2)

  3. Functional connectivity

    Time frame: Once before and once immediately after intervention

    fMRI

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Focused Ultrasound Foundation

Registry information

Official study title

Effectiveness of Targeting the Zona Incerta (ZI) for Tremor Control in Parkinson's Disease Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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